Manufacturing Equipment, Upstream Processing

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.

The adoption of perfusion cell culture continues to advance with the help of PAT tools.

Large-scale single-use bioreactors prove successful as limits are tested.

SUB bioreactor performance has had seen its limits and successes.

CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.

Advancements in bioprocessing technologies test microbial fermentation adaptability.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

The acquisition of Intermountain Life Sciences will double Cytiva’s capacity for buffers and liquid cell culture media at its manufacturing site in Logan, Utah.

Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.

Demand for recombinant microorganism-based cell culture supplements is rising on the back of lower contamination risk.

Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.

The innovation of single-use technologies is applicable early on in the manufacturing process.

Overcoming time and cost constraints can help enable seed train intensification efforts to maximize product yield.

Establishing an automated inline dilution system can potentially ease bottlenecking delays resulting from higher upstream yields.

PAT advances are enabling improved process understanding, process control, and error prevention.

An innovation such as synthetic biology can develop a consistently stable starting cell line for cell therapy source material.

Bioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.

The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.

This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Synthetic biology has advanced the scope and scale with which biologically derived therapeutics can be developed.

GEA began supplying the new GEA Hilge Novatwin hygienic twin-screw pump line.

The new BIOSTAT STR Generation 3 with BIOBRAIN bioproduction platform offers process intensification with automated feed and bleed and integrated cell retention functionality.

The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.

Industry experts debate the pros and cons of “going bigger” than the 2000-L industry norm in a single vessel.

The latest advances in upstream technologies include single-use equipment and a protein analyzer for titer monitoring, as well as new plasmid DNA manufacturing capability.

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.